Safety and Efficacy of Ceftolozane/Tazobactam Versus Meropenem in Neonates and Children With Complicated Urinary Tract Infection, Including Pyelonephritis: A Phase 2, Randomized Clinical Trial.

Autor:	Roilides E; From the Third Department of Pediatrics, Infectious Diseases Unit, School of Medicine, Aristotle University and Hippokration General Hospital, Thessaloniki, Greece., Ashouri N; Division of Infectious Diseases, CHOC Children's Hospital, Orange, California., Bradley JS; Department of Pediatrics, University of California San Diego School of Medicine and Rady Children's Hospital of San Diego, San Diego, California., Johnson MG; Merck & Co., Inc., Rahway, New Jersey., Lonchar J; Merck & Co., Inc., Rahway, New Jersey., Su FH; Merck & Co., Inc., Rahway, New Jersey., Huntington JA; Merck & Co., Inc., Rahway, New Jersey., Popejoy MW; Merck & Co., Inc., Rahway, New Jersey., Bensaci M; Merck & Co., Inc., Rahway, New Jersey., De Anda C; Merck & Co., Inc., Rahway, New Jersey., Rhee EG; Merck & Co., Inc., Rahway, New Jersey., Bruno CJ; Merck & Co., Inc., Rahway, New Jersey.
Jazyk:	angličtina
Zdroj:	The Pediatric infectious disease journal [Pediatr Infect Dis J] 2023 Apr 01; Vol. 42 (4), pp. 292-298. Date of Electronic Publication: 2023 Jan 23.
DOI:	10.1097/INF.0000000000003832
Abstrakt:	Background: Ceftolozane/tazobactam, a cephalosporin-β-lactamase inhibitor combination, active against multidrug-resistant Gram-negative pathogens, is approved for treatment of adults with complicated urinary tract infections (cUTI). Safety and efficacy of ceftolozane/tazobactam in pediatric participants with cUTI, including pyelonephritis, were assessed. Methods: This phase 2 study (NCT03230838) compared ceftolozane/tazobactam with meropenem for treatment of cUTI in participants from birth to <18 years of age. The primary objective was safety and tolerability. Key secondary end points included clinical cure and per-participant microbiologic response rates at end of treatment (EOT) and test of cure (TOC) visits. Results: The microbiologic modified intent-to-treat (mMITT) population included 95 participants (ceftolozane/tazobactam, n = 71; meropenem, n = 24). The most common diagnosis and pathogen were pyelonephritis (ceftolozane/tazobactam, 84.5%; meropenem, 79.2%) and Escherichia coli (ceftolozane/tazobactam, 74.6%; meropenem, 87.5%); 5.7% (ceftolozane/tazobactam) and 4.8% (meropenem) of E. coli isolates were extended-spectrum β-lactamase-producers. Rates of adverse events were similar between treatment groups (any: ceftolozane/tazobactam, 59.0% vs. meropenem, 60.6%; drug-related: ceftolozane/tazobactam, 14.0% vs. meropenem, 15.2%; serious: ceftolozane/tazobactam, 3.0% vs. meropenem, 6.1%). Rates of clinical cure for ceftolozane/tazobactam and meropenem at EOT were 94.4% and 100% and at TOC were 88.7% and 95.8%, respectively. Rates of microbiologic eradication for ceftolozane/tazobactam and meropenem at EOT were 93.0% and 95.8%, and at TOC were 84.5% and 87.5%, respectively. Conclusions: Ceftolozane/tazobactam had a favorable safety profile in pediatric participants with cUTI; rates of clinical cure and microbiologic eradication were high and similar to meropenem. Ceftolozane/tazobactam is a safe and effective new treatment option for children with cUTI, especially due to antibacterial-resistant Gram-negative pathogens. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
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